Atrial fibrillation (“AF”) is the most common sustained cardiac arrhythmia in the world. There are thought to be over 2.3 million Americans that are living with atrial fibrillation.1 In 1914, Garrey2 theorized that a critical mass of tissue was necessary to maintain atrial fibrillation.3 Garrey2 theorized that multiple wavelets circulated through the atria around transitory and shifting lines of block, activating the atria in a chaotic manner that sustained atrial fibrillation. Using computer modeling, researchers4,5 demonstrated that multiple wavelet reentry theoretically could be used as a mechanism to sustain atrial fibrillation. Others subsequently confirmed multiple wavelet reentry as a cause of atrial fibrillation in studies in animals and humans.6,7 Weiner and Rosenbluth8 introduced the concept of wavelength, defined as the product of refractory period and conduction velocity (“CV”), which represents the minimum path length needed for reentry in sustained atrial fibrillation.
There has been developed a Maze procedure that divides the atrium into a maze and prevents macro circuit reentry, while still allowing for normal sinus activation of the atrium. Recent long-term follow-up data demonstrated a success rate of greater than ninety percent (90%). Although a successful procedure, there still remains a subset of patients for which this procedure does not cure of atrial fibrillation.
Kosakai11 examined their operative experience and found a decreasing success rate with increasing preoperative atrial sizes. When the left atria (“LA”) diameter was less than forty-five (45) millimeters, the success rate in conversion to normal sinus rhythm (“NSR”) after the Maze procedure was one hundred percent (100%). When the diameter was over eighty-seven (87) millimeters, there was a zero percent (0%) success rate for conversion to normal sinus rhythm after the Maze procedure. It is hypothesized that the Maze procedure does not divide the atria into small enough sections to prevent atrial fibrillation in patients with an enlarged atria.
At the present time, all surgical operations, including the Maze procedure, e.g., Maze III procedure and the Maze IV procedure, and pulmonary vein isolation, are based on encircling anatomic landmarks. The theory behind these procedures was that atrial fibrillation originates either from the pulmonary veins or is due to reentry around the mitral or tricuspid annuli, pulmonary veins, or the inferior or superior vena cava. The Maze III procedure was developed in an attempt to stop the multiple macroreentrant circuits felt to be responsible for atrial fibrillation. Recently, other investigators have pointed to the importance of pulmonary veins as triggers for atrial fibrillation. This has resulted in attempts to anatomically isolate the pulmonary veins. Unfortunately, current surgical approaches to the treatment of atrial fibrillation have had success rates that have ranged from ten percent (10%) to ninety percent (90%). There is a need for a treatment having a much higher and constant success rate. The present invention is directed to overcoming one or more of the problems set forth above and could be applied to any catheter-based or surgical intervention.